CEO Lee Doohyun: "Opirangerin Confident to Dominate Global Painkiller Market for 30 Years"

Vivozon Starts Phase 3 Clinical Trial of Opiranserin in the US
Lumimicro Prepares for Future Pharmaceutical Business
Pipeline Expansion through Technology Licensing and M&A

[Asia Economy Reporter Hyungsoo Park] Vivozon has initiated the Phase 3 clinical trial of the non-narcotic analgesic Opiranserin in the United States. The pharmaceutical commercialization that can create synergy with Lumimicro is also progressing smoothly.

Lee Doohyun, CEO of Vivozon, announced on the company website on the 26th, "The first patient dosing for the Phase 3 clinical trial targeting patients undergoing thumb bunion (hallux valgus) excision surgery has been conducted, officially starting the Phase 3 trial."

He added, "We aim to dose about 300 patients by the end of October and to produce topline results by the end of this year or early next year."

In the Phase 2b clinical trial for thumb bunion announced last November, Vivozon did not meet the 12-hour pain area endpoint due to a small number of patients. The trial is currently recruiting with a goal of enrolling a total of 300 patients. The design of the Phase 2b trial has been refined.

In Phase 2b, a significant reduction in pain was confirmed within one hour. More than 70% of patients administered Opiranserin experienced almost immediate pain relief, according to CEO Lee. When the analysis included only patients with pain intensity of 7 or higher, the sum of pain intensity area was statistically significant, and the average pain intensity was confirmed to be more than 2 points lower compared to the placebo group.

CEO Lee emphasized, "Global pharmaceutical companies have made every effort to develop non-narcotic analgesics but have repeatedly failed. There has been no example of a systemically administered drug showing as consistently positive results as Opiranserin." He added, "Considering this situation, last year's Phase 3 clinical trial failure can rather be seen as an opportunity for a turnaround."

Furthermore, he explained, "In the newly conducted Phase 3 trial, the method to exclude patients with mild pain has been clearly defined," and "the opioid dosage has been more precisely adjusted to achieve successful results."

Regarding the Phase 3 clinical trial for abdominoplasty patients, CEO Lee said, "We are currently deliberating on the start time," and "Once a final decision is made, we will report it through an official announcement."

He also disclosed information about pharmaceutical commercialization through Lumimicro. He stated that through fundraising via Lumimicro, the goal of creating a global pharmaceutical company originating from Korea can be pursued.

CEO Lee said, "Pharmaceutical commercialization through Lumimicro is also progressing simultaneously without any setbacks," and "We are preparing for future pharmaceutical commercialization beyond the current pharmaceutical business standards."

Regarding the possibility of a reverse merger through Lumimicro, he emphasized, "Regarding listing, we will proceed in a way that maximizes the interests of Vivozon shareholders," and "We will be able to review whether Lumimicro is a suitable partner, and if there is synergy, we believe we can join forces."

On the progress of Vivozon's pipeline, CEO Lee stated, "Preclinical toxicity tests for candidates related to neuropathic pain and drug addiction are planned," and "We expect to enter Phase 1 clinical trials in the fourth quarter of next year." He added, "Another candidate drug with the same mechanism as Opiranserin will begin preclinical toxicity testing this year."

He said, "If successful development is achieved for Opiranserin and additional analgesic candidates, Vivozon can dominate the global analgesic market for at least the next 30 years," and "We plan to expand the pipeline through technology transfers from bio ventures such as immuno-oncology or by acquiring companies themselves."

This content was produced with the assistance of AI translation services.